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**Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Office **Job Description** We are looking for a **Clinical Research Associate I (CRA I)** to join our clinical operations team in Italy. As a **CRA** I, you will perform and coordinate clinical monitoring and site management activities across investigator sites. Working through a combination of on-site and remote monitoring, you will help ensure that clinical trials are conducted in accordance with the approved protocol, ICH-GCP, applicable regulatory requirements and standard operating procedures (SOPs). You will act as a key point of contact for investigational sites, helping safeguard participants’ rights, safety and well-being while supporting the quality, integrity and reliability of clinical trial data. What you’ll do -------------- * Monitor investigator sites using a risk-based monitoring approach, conducting on-site and remote monitoring activities in accordance with the approved monitoring plan. * Perform source data review (SDR), source data verification (SDV) and case report form (CRF) review, as applicable, to support data quality and integrity. * Assess site compliance with the study protocol, ICH-GCP, applicable regulations, SOPs and project-specific requirements. * Apply critical thinking, root cause analysis and problem-solving techniques to identify site-level issues and support appropriate corrective and preventive actions. * Review investigational product accountability through physical inventory and associated records, as required. * Document monitoring observations clearly and accurately in reports and follow-up correspondence within required timelines. * Identify and escalate significant issues and deficiencies to clinical management and follow actions through to resolution. * Maintain regular communication with investigational sites between monitoring visits, as required, to support protocol compliance, timely data entry and resolution of outstanding issues. * Conduct site initiation, routine monitoring and close-out activities in accordance with relevant procedures and project requirements. * Ensure essential study documentation is complete, accurate and maintained in accordance with ICH-GCP and applicable regulatory requirements. * Conduct investigator site file reviews in line with project specifications. * Participate in investigator meetings and, where required, support the identification and assessment of potential investigator sites. * Maintain accurate and timely study information in relevant systems, including the Clinical Trial Management System (CTMS). * Provide study status updates and progress reports to project teams as required. * Facilitate effective communication between investigational sites, sponsors and internal project teams. * Support responses to sponsor requirements, audits, regulatory inspections and other quality activities. * Participate in investigator payment processes, where applicable. * Complete administrative activities, including timesheets and expense reports, accurately and on time. * Contribute to project initiatives, study tools and continuous process improvement activities. About you --------- You will bring a strong scientific background together with clinical research experience and an interest in developing your career in clinical monitoring. **You will have:** * A degree in Life Sciences, Pharmacy, Medicine or another relevant scientific discipline, together with appropriate academic and/or professional qualifications. * Relevant clinical research and monitoring experience, typically equivalent to approximately **2 years of clinical monitoring experience**. * A working knowledge of ICH-GCP and the ability to develop and maintain knowledge of applicable clinical trial regulations, procedures and study documentation. * An understanding of clinical trial monitoring and risk-based monitoring principles. * Basic medical and therapeutic area knowledge, with a good understanding of medical terminology. * Strong organisational and time-management skills, with the ability to manage multiple priorities effectively. * Good critical-thinking and problem-solving skills, including the ability to investigate issues and identify appropriate root causes and solutions. * Strong interpersonal skills and the ability to build effective relationships with investigator sites, medical professionals, sponsors and internal colleagues. * Good written and verbal communication skills. * A collaborative approach, with the ability to work effectively both independently and as part of a team. * Strong attention to detail and a commitment to quality. * Good computer skills, including Microsoft Office, with the ability to learn and work confidently with clinical trial systems and software. * Good written and spoken English. * A valid driving licence, where required for the role. Travel and working environment ------------------------------ * This is a field-based clinical monitoring role requiring **frequent travel to investigator sites, typically around 60–80%**, depending on study and business requirements. Travel may include overnight stays. * Depending on the investigator site and study requirements, appropriate personal protective equipment (PPE), such as protective eyewear, garments or gloves, may be required. Why join us? ------------ At Thermo Fisher Scientific, you’ll join a global organisation where your work can directly contribute to the development of new and potentially life-changing therapies. You’ll collaborate with experienced clinical research professionals, work across diverse studies and therapeutic areas, and have opportunities to develop your clinical monitoring expertise and career within a global organisation. Our teams are united by a shared commitment to quality, collaboration and our Mission – **to enable our customers to make the world healthier, cleaner and safer.** **Join us and help shape the future of clinical research.**